India’s health regulator Drugs Controller General of India (DCGI) has granted Emergency Use Authorization (EUA) to two vaccines, Covaxin andCovishield , to fight the COVID-19 pandemic.

Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and National Institute of Virology (NIV).

Covishield has been developed by Oxford University scientists in collaboration with pharmaceutical company AstraZeneca. In India, its trial was undertaken by the Serum Institute of India, which is also manufacturing the Covishield vaccine.

Bhupendra Chaubey, Editor-In-Chief at India Ahead News, spoke to Kiran Mazumdar-Shaw on the row over Bharat Biotech’s Covaxin, the question of the efficacy of COVID-19 vaccines and what people should watch out for when it comes to the immunisation process.

Bhupendra Chaubey: As an entrepreneur invested in Science, how do you see the approvals coming for both Covaxin and Covishield?

Kiran Mazumdar-Shaw: India has been anxiously waiting for a vaccine and the approvals of both the vaccines, Covaxin and Covishield, come as huge respite to 1.3 billion people in the country.

The vaccines have been approved by DCGI as they have demonstrated safety and immunogenicity. Both the vaccines have provided data which show that they are safe. The regulator has used scientific judgement in deciding on approving these vaccines.

Bharat Biotech’s vaccine, Covaxin, has demonstrated safety and immunogenicity in Phase 1 and Phase 2 clinical trials. Covaxin has been evaluated in ~1,000 subjects in the first two phases, with promising safety and immunogenicity results.

The Phase 3 human clinical trials of Covaxin is targeted to be done in 26,000 volunteers across India, making it the largest Phase 3 efficacy trial ever conducted for any vaccine in India, according to Bharat Biotech.

Moreover, the product development and clinical trial data thus far has generated five publications, four of which have been accepted by international peer reviewed journals and will be published soon.

So, the dataset on safety and immunogenicity for Covaxin is pretty vast. On the aspect of the vaccine’s efficacy, the DCGI has also gone ahead with the understanding the efficacy data will not be available until end of February. The regulator has extrapolated the available safety and immunogenicity data for Covaxin to conclude it crosses the 50% efficacy threshold while granting permission for emergency use of the vaccine. 

Covaxin has thus been approved by the regulator with the pre-condition that it can be administered as part of an extended, open label clinical trial. This means in the case of Covaxin, patient consent will be needed before administration. Also, there will be follow-up of vaccinated patients, their immunogenicity response will be measured and more data on the vaccine has to be generated by Bharat Biotech thereafter. So it’s going to be a much more elaborate process. 

For Covishield, Serum Institute has provided data from a small cohort of people who participated in the company’s bridging trials for the Oxford University-AstraZeneca vaccine in India to show that its safety and immunogenicity matches data from the global clinical trials. Serum has also provided the DCGI with efficacy data from the global trials of the Oxford University-AstraZeneca vaccine. Based on these datasets, the Indian regulator has rightly given an EUA for Covishield. 

Bhupendra Chaubey: Think as citizens, when DCGI says that the phase III data will not be available till a certain time period, but that vaccine is being made available, what would the citizens feel?

Kiran Mazumdar-Shaw: Under normal circumstances, efficacy data is required over a one-year period. None of the approved vaccines have provided efficacy data for that duration. Given that we are facing a public health emergency, the regulator has accepted short-term efficacy data but asked all vaccine companies to keep collecting long term efficacy data.

India needs a vaccine urgently and the DCGI and the Subject Expert Committee (SEC) have used scientific judgement in evaluating the available data on these two vaccine candidates in granting Emergency Use Authorization.

Serum’s Covishield vaccine has been given a “freer” EUA because there is efficacy, safety and immunogenicity data.

For Bharat Biotech’s Covaxin, the regulator has taken a call based on science to give a EUA with “stricter” controls as Phase 3 efficacy data for the vaccine is as yet unavailable.

Bhupendra Chaubey: What about the other companies? What about Moderna, Pfizer in UK. Can you help us understand is there a difference between India scenario and UK scenario?

Kiran Mazumdar-Shaw: The efficacy data that has been provided thus far by Moderna, Pfizer or Astrazeneca is abbreviated. Under normal circumstances, these would not have been accepted. Because it’s a public health emergency and a pandemic, regulators have accepted a much shorter efficacy data. By extrapolating available data, the DCGI has concluded the Bharat Biotech vaccine will pass the 50% efficacy threshold. That’s the basis on which they have given approval to Covaxin.

Bhupendra Chaubey: So, what’s the difference between what is being said by Bharat Biotech and what is being said by AstraZeneca?

Kiran Mazumdar-Shaw: The difference between AstraZeneca vaccine approval and Bharat Biotech vaccine approval is that the AstraZeneca vaccine approval is an Emergency Use Authorization where they don’t need to administer the vaccine in a clinical trial. They are allowed to vaccinate people as in emergency use. 

The Bharat Biotech vaccine has to be administered in a clinical trial, which means they have to get consent, they have to follow up with those patients, they have to measure their immunogenicity response, they have to follow it right up to the second dose and they have to get more data thereafter. So, it’s not an easy process. Rather, it is a much more elaborate process. 

Bhupendra Chaubey: But what would you be comfortable with? What should people be watching out for when it comes to the process of vaccination?

Kiran Mazumdar-Shaw: I would suggest going for either of the two vaccines because what you currently need is an immunogenic response. What we require from a vaccine is to boost our immunity and a good immunogenic response. 

Since people prefer to use a vaccine which has efficacy data so a lot of people will prefer to use AstraZeneca vaccine at the moment but those who want access to a vaccine can take Bharat Biotech vaccine and follow it up. The efficacy data for the Bharat Biotech vaccine is expected to come out by February end.

The other 2 vaccines  by Pfizer and Moderna   present a challenge for us in India  as they need an ultra cold supply chain network for transportation. Also, they have a manufacturing capacity issue so these vaccines will not be available to countries like ours for a very long time. 

Watch the India Ahead News interview here:

Watch the Mojo Story, interview with Barkha Dutt here:

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